Method and apparatus for fixing a graft in a bone tunnel

ABSTRACT

A method and apparatus for fixing a ligament in a bone tunnel by cross-pinning the ligament in the bone tunnel.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of prior U.S. patent applicationSer. No. 10/436,038 filed on May 12, 2003 and entitled “Method andApparatus for Fixing a Graft in a Bone Tunnel,” now U.S. Pat. No.7,594,917, which is a continuation-in-part of prior U.S. patentapplication Ser. No. 10/364,786 filed on Feb. 11, 2003 and entitled“Method and Apparatus for Fixing a Graft in a Bone Tunnel,” now U.S.Pat. No. 6,958,067, which is a continuation of U.S. patent applicationSer. No. 09/865,274 filed on May 25, 2002 and entitled “Method andApparatus for Fixing a Graft in a Bone Tunnel,” now U.S. Pat. No.6,517,546, which claims priority to U.S. Provisional Application Ser.No. 60/275,431 filed on Mar. 31, 2001 and entitled “Method and Apparatusfor Fixing a Graft in a Tibial Tunnel.” These references are herebyincorporated herein in their entireties.

FIELD OF THE INVENTION

This invention relates to surgical methods and apparatus in general, andmore particularly to methods and apparatus for fixing a graft in a bonetunnel.

BACKGROUND OF THE INVENTION

The complete or partial detachment of ligaments, tendons and/or othersoft tissues from their associated bones within the body are relativelycommonplace injuries. Tissue detachment may occur as the result of anaccident such as a fall, overexertion during a work-related activity,during the course of an athletic event, or in any one of many othersituations and/or activities. Such injuries are generally the result ofexcess stress being placed on the tissues.

In the case of a partial detachment, commonly referred to under thegeneral term “sprain”, the injury frequently heals itself, if givensufficient time and if care is taken not to expose the injury to unduestress during the healing process. If, however, the ligament or tendonis completely detached from its associated bone or bones, or if it issevered as the result of a traumatic injury, partial or permanentdisability may result. Fortunately, a number of surgical proceduresexist for re-attaching such detached tissues and/or completely replacingseverely damaged tissues.

One such procedure involves the re-attachment of the detached tissueusing “traditional” attachment devices such as staples, sutures and/orcancellous bone screws. Such traditional attachment devices have alsobeen used to attach tendon or ligament grafts (often formed fromautogenous tissue harvested from elsewhere in the body) to the desiredbone or bones.

Another procedure is described in U.S. Pat. No. 4,950,270, issued Aug.21, 1990 to Jerald A. Bowman et al. In this procedure, a damagedanterior cruciate ligament (“ACL”) in a human knee is replaced by firstforming bone tunnels through the tibia and femur at the points of normalattachment of the anterior cruciate ligament. Next, a graft ligament,with a bone block on one of its ends, is sized so as to fit within thebone tunnels. Suture is then attached to the bone block, and the sutureis thereafter passed through the tibial tunnel and then the femoraltunnel. The bone block is then drawn up through the tibial tunnel and upinto the femoral tunnel using the suture. As this is done, the graftligament extends back out the femoral tunnel, across the interior of theknee joint, and then out through the tibial tunnel. The free end of thegraft ligament resides outside the tibia, at the anterior side of thetibia. Next, a bone screw is inserted between the bone block and thewall of femoral bone tunnel so as to securely lock the bone block inposition by a tight interference fit. Finally, the free end of the graftligament is securely attached to the tibia.

In U.S. Pat. No. 5,147,362, issued Sep. 15, 1992 to E. Marlowe Goble,there is disclosed a procedure wherein aligned femoral and tibialtunnels are formed in a human knee. A bone block, with a graft ligamentattached thereto, is passed through the tibial and femoral tunnels to ablind end of the femoral tunnel, where the block is fixed in place by ananchor. The graft ligament extends out the tibial tunnel, and theproximal end thereof is attached to the tibial cortex by staples or thelike. Alternatively, the proximal end of the ligament may be fixed inthe tibial tunnel by an anchor or by an interference screw.

Various types of ligament and/or suture anchors, and anchors forattaching other objects to bone, are also well known in the art. Anumber of these devices are described in detail in U.S. Pat. Nos.4,898,156; 4,899,743; 4,968,315; 5,356,413; and 5,372,599.

One known method for anchoring bone blocks in bone tunnels is through“cross-pinning”, in which a pin, screw or rod is driven into the bone,transversely to the bone tunnel, so as to intersect the bone block andthereby “cross-pin” the bone block in the bone tunnel.

In this respect it should be appreciated that the cross-pin (i.e., theaforementioned pin, screw or rod) is generally placed in a pre-drilledtransverse passageway. In order to provide for proper cross-pinning ofthe bone block in the bone tunnel, a drill guide is generally used. Thedrill guide serves to ensure that the transverse passageway ispositioned in the bone so that the transverse passageway intersects theappropriate tunnel section and hence the bone block. Drill guides foruse in effecting such transverse drilling are shown in U.S. Pat. Nos.4,901,711; 4,985,032; 5,152,764; 5,350,380; and 5,431,651.

Other patents in which cross-pinning is discussed include U.S. Pat. Nos.3,973,277; 5,004,474; 5,067,962; 5,266,075; 5,356,435; 5,376,119;5,393,302; and 5,397,356.

Cross-pinning methods and apparatus currently exist for fixing a graftligament in a femoral bone tunnel. However, the femoral cross-pinningmethods and apparatus that are presently known in the art do not addressthe use of a cross-pin in a tibial bone tunnel, which involves adifferent set of considerations. Among these considerations areanatomical geometries, bone configurations, bone quality, etc.

Accordingly, there exists a need for a method and apparatus forpositioning at least one cross-pin so as to fix a graft in a tibial bonetunnel.

There also exists a need for a method and apparatus for positioning atleast one cross-pin across a tibial tunnel such that, upon completion ofthe procedure, the cross-pin is located in the cortical portion of thetibia, adjacent to the tibial plateau.

SUMMARY OF THE INVENTION

One object of the present invention is, therefore, to provide a novelmethod and apparatus for positioning at least one cross-pin so as to fixa graft in a tibial bone tunnel.

Another object of the present invention is to provide a novel method andapparatus for positioning at least one cross-pin across a tibial tunnelsuch that, upon completion of the procedure, the cross-pin is located inthe tibia and, more preferably, in the cortical portion of the tibia,adjacent to the tibial plateau.

These and other objects of the present invention are addressed by theprovision and use of a novel method and apparatus for fixing a graft ina bone tunnel.

In accordance with a feature of the present invention, there is providedapparatus for positioning at least one cross-pin in a bone through abone tunnel, the apparatus comprising: a bone tunnel guide rod having aproximal end and a distal end; a movable element slidably positionedabout the bone tunnel guide rod, wherein said movable element islockable into a position to selectively adjust the length of said guiderod between said distal end and said movable element; a frame memberhaving a base portion and an arm portion, the base portion attachable tothe proximal end of the bone tunnel guide rod; a drill guide memberattachable to the arm portion of the frame member; and drilling meansfor drilling at least one cross-pin hole in the bone and across the bonetunnel, with the drilling means being supported in position by the drillguide member, the drill guide member being in attachment with the framemember, the frame member being in attachment with the bone tunnel guiderod, and the bone tunnel guide rod being inserted into the bone tunnel,and the apparatus being held against the bone, with the movable elementlimiting further insertion into the bone tunnel.

In accordance with a further feature of the present invention, there isprovided a method for fixing a ligament in a bone tunnel, the methodcomprising the steps of: forming a bone tunnel in a bone, the bonetunnel comprising a first open end and a second open end, with a portionbetween the first open end and the second open end having a diametersized to receive the ligament; inserting a guide rod into the bonetunnel, the guide rod having a proximal end and a distal end;positioning the distal end of the guide rod adjacent to the second openend of the bone tunnel; positioning a movable element on the guide rodagainst the bone at the first open end of the bone tunnel; drilling atleast one cross-pin hole transversely through the bone and across thebone tunnel, using drilling means for drilling the cross-pin hole, thedrilling means being supported in position by a drill guide member, withthat drill guide member being in attachment with a frame member, theframe member being in attachment with the bone S tunnel guide rod, thebone tunnel guide rod being inserted into the bone tunnel, and with themovable element limiting further insertion of the bone tunnel guide rodinto the bone tunnel; and inserting at least one cross-pin through atleast one cross-pin hole.

In accordance with a further feature of the present invention, there isprovided an apparatus for positioning at least one cross-pin in a bonethrough a bone tunnel, the apparatus comprising: a bone tunnel guide rodhaving a proximal end and a distal end, with the bone tunnel guide rodhaving a gradiated index between the proximal end and the distal end,wherein the gradiated index is read at a given position in the bonetunnel in relation to an intended position of at least one cross-pinhole; a frame member having a base portion and an arm portion, the baseportion attachable adjacent to the proximal end of the bone tunnel guiderod, and the arm portion of the frame member having a scalecorresponding with the gradiated index of the bone tunnel guide rod; adrill guide member attachable to the arm portion of the frame member,the drill guide member being selectively adjustable relative to thescale of the frame member; and drilling means for drilling the at leastone cross-pin hole in the bone through the bone tunnel, the drillingmeans being supported in position by the drill guide member, the drillguide member being in attachment with the frame member, and the framemember being in attachment with the bone tunnel guide rod, with the bonetunnel guide rod being inserted into the bone tunnel, with the distalend of apparatus being held against a terminal end of the bone tunnel,limiting further insertion into the bone tunnel.

In accordance with a further feature of the present invention, there isprovided a method for fixing a ligament in a bone tunnel, the methodcomprising the steps of: forming a bone tunnel in a bone, the bonetunnel comprising a first portion and a second portion, the firstportion having a first open end and a second open end, and the secondportion having a third open end and a fourth terminal end, and a portionbetween the first open end and the fourth terminal end having a diametersized to receive the ligament; inserting a bone tunnel guide rod intothe bone tunnel, the bone tunnel guide rod having a proximal end and adistal end, and the bone tunnel guide rod having a gradiated indexbetween the proximal end and the distal end; positioning the distal endof the guide rod against the fourth terminal end of the bone tunnel;determining the position of the gradiated index relative to the secondopen end of the bone tunnel; positioning a drill guide attached to aframe member, the frame member including a scale corresponding with thegradiated index of the bone tunnel guide rod, the drill guide beingpositioned relative to the scale in accordance with the gradiated indexrelative to the second open end of the bone tunnel; drilling at leastone cross-pin hole transversely through the bone into the bone tunnelusing drilling means for drilling the cross-pin hole, the drilling meanssupported in position by the drill guide member, the drill guide memberbeing in attachment with the frame member, the frame member being inattachment with the bone tunnel guide rod, the bone tunnel guide rodbeing inserted into the bone tunnel, and the fourth terminal end of thebone tunnel limiting further insertion into the bone tunnel; andinserting at least one cross-pin through the cross-pin hole.

In accordance with a further feature of the present invention, there isprovided an apparatus for positioning at least one cross-pin in a bonethrough a bone tunnel, the apparatus comprising: a kit of bone tunnelguide rods, each of the bone tunnel guide rods including a proximal endand a distal end, and each of the bone tunnel guide rods includinginsertion limiting means for limiting insertion into the bone tunnel,the insertion limiting means of each of the bone tunnel guide rods beinglocated a given distance from its distal end, the kit including at leasttwo bone tunnel guide rods, with the given distance of each of the bonetunnel guide rods being different from one another, and whereinselection from the kit is made by inserting at least one of the bonetunnel guide rods into the bone tunnel and selecting a bone tunnel guiderod that has its distal end aligned with a bone surface when saidinsertion limiting means is in engagement with another bone surface; aframe member having a base portion and an arm portion, the base portionattachable adjacent to the proximal end of the selected bone tunnelguide rod; a drill guide member attached to the arm portion of the framemember; drilling means for drilling the at least one cross-pin hole inthe bone through the bone tunnel, the drilling means being supported inposition by the drill guide member, the drill guide member being inattachment with the frame member, and the frame member being inattachment with the selected bone tunnel guide rod, with the selectedbone tunnel guide rod being inserted into the bone tunnel, and with theinsertion limiting means preventing further insertion into the bonetunnel.

In accordance with a further feature of the present invention, there isprovided a method for fixing a ligament in a bone tunnel, the methodcomprising the steps of: forming a bone tunnel in a bone, the bonetunnel comprising a first open end and a second open end, with a portionbetween the first open end and the second open end having a diametersized to receive the ligament; inserting at least one guide rod from akit of bone tunnel guide rods into the bone tunnel, each of the bonetunnel guide rods including a proximal-end and a distal end, and each ofthe bone tunnel guide rods including insertion limiting means forlimiting insertion into the bone tunnel, the insertion limiting means ofeach of the bone tunnel guide rods being located a given distance fromits distal end, the kit including at least two bone tunnel guide rods,with the given distance of each of the bone tunnel guide rods beingdifferent from one another; inserting at least one of the bone tunnelguide rods into the bone tunnel and selecting a bone tunnel guide rodthat has its distal end aligned with the second end of the bone tunnelwhen the insertion limiting means is in engagement with the boneadjacent the first end of the bone tunnel; drilling at least onecross-pin hole transversely through the bone and across the bone tunnel,using drilling means for drilling the cross-pin hole, the drilling meansbeing supported in position by a drill guide member, with the drillguide member being in attachment with a frame member, the frame memberbeing in attachment with the selected bone tunnel guide rod, theselected bone tunnel guide rod being inserted into the bone tunnel, andwith the insertion limiting means limiting further insertion of the bonetunnel guide rod into the bone tunnel; and inserting at least onecross-pin through said at least one cross-pin hole.

In accordance with a further feature of the present invention, there isprovided an apparatus for positioning at least one cross-pin in a bonethrough a bone tunnel, the apparatus comprising: a bone tunnel guide rodhaving a proximal end and a distal end; a frame member having a baseportion and an arm portion, the base portion attachable adjacent to theproximal end of the bone tunnel guide rod; at least one slot in the armportion, the at least one slot being cammed outwardly toward the baseportion relative to the bone tunnel guide rod; a drill guide memberslidably connected with the at least one slot in the arm portion; and aprobe connected to the drill guide member, the probe attachable to thedistal end of the bone tunnel guide member such that the probe acts toguide member such that the probe acts to guide the positioning of the atleast one cross-pin in the bone tunnel; and drilling means for drillingat least one cross-pin hole in the bone and across the bone tunnel, withthe drilling means being supported in position by the drill guidemember, the drill guide member in slidable connection with the framemember being in attachment with the bone tunnel guide rod, and the bonetunnel guide rod being inserted into the bone tunnel, and the probebeing attached to the distal end of the bone tunnel guide rod toposition the drill guide member to place at least one cross-pin hole inbone through a bone tunnel and allow the drill guide member to adjustrelative to a changing angle and distance relative to a desiredcross-pin site.

In accordance with a further feature of the present invention, there isprovided a method for fixing a ligament in a bone tunnel, the methodcomprising the steps of: forming a bone tunnel in a bone, the bonetunnel comprising a first open end and a second open end, with a portionbetween the first open end and the second open end, with a portionbetween the first open end and the second open end having a diametersized to receive the ligament; inserting a bone tunnel guide rod intothe bone tunnel, the bone tunnel guide rod having a proximal end and adistal end; positioning a drill guide member slidably connected with aframe member, the frame member, being attached to the proximal end ofthe drill guide member, the frame member having a probe connected to thedrill guide member, with the drill guide member being positioned so thatthe probe is connected to the distal end of the bone tunnel guide rod,with such positioning causing the drill guide member to adjust to achanging angle and distance relative to a desired cross-pin site;drilling at least one cross-pin hole transversely through the bone andacross the bone tunnel, using drilling means for drilling the cross-pinhole, the drilling means being supported in position by the drill guidemember, with the drill guide member being in slidable attachment withthe frame member, the frame member being in attachment with the proximalend of the bone tunnel guide rod, the bone tunnel guide rod beinginserted into the bone tunnel, and with the probe being in engagementwith the distal end of the bone tunnel guide rod; and inserting at leastone cross-pin through the at least one cross-pin hole.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and features of the present invention willbe more fully discussed in, or rendered obvious by, the followingdetailed description of the preferred embodiments of the invention,which is to be considered together with the accompanying drawingswherein like numbers refer to like parts, and further wherein:

FIG. 1-13 are various views of one form of a cross-pin guide assemblyfor use in cross-pinning a graft in a tibial tunnel, illustrative of onepreferred embodiment of the present invention;

FIG. 14 is a diagrammatical view of a human knee joint and illustrativeof a step in a method in which the cross-pin guide assembly of FIGS.1-13 is used;

FIGS. 15-34 are diagrammatical views illustrating a ligamentreconstruction procedure in which the cross-pin guide of FIGS. 1-13 isused;

FIGS. 35-38 are various views of another form of a cross-pin guideassembly for use in cross-pinning a graft in a tibial tunnel,illustrative of another preferred embodiment of the present invention;

FIG. 39 is a schematic view of a kit of bone tunnel guide rods for usewith a third embodiment of the present invention;

FIG. 40 is a schematic view showing one of the bone tunnel guide rods ofFIG. 39 with an associated cross-pin guide assembly;

FIG. 41 is a schematic view illustrating certain aspects of drilling abone tunnel in bone; and

FIGS. 42-44 are schematic views of another form of cross-pin guideassembly formed in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Looking first at FIGS. 1-10, there is shown a cross-pin guide assembly 5for placement of at least one cross-pin (not shown in FIGS. 1-10) in abone tunnel, such as the tibial tunnel of a knee joint. Cross-pin guideassembly 5 comprises an L-shaped member 10 having a base portion 15 andan arm portion 20. The arm portion 20 extends transversely to, andpreferably is normal to, base portion 15.

Cross-pin guide assembly 5 further comprises a bone tunnel guide rod 25which, adjacent to a first end 30 thereof, forms a diametrical,longitudinally-elongated passageway 35, and which, at a second end 40thereof, is releasably connectable to base portion 15 of L-shaped member10. In a preferred embodiment, bone tunnel guide rod 25 is cannulatedalong its axis 65 (see FIGS. 1-10) for placement on a guidewire (notshown in FIGS. 1-10). Bone tunnel guide rod 25 may be retained in a bore45 formed in base portion 15 by a set screw 50. In an alternativeembodiment, bone tunnel guide rod 25 may be fixedly connected to baseportion 15.

Still looking at FIGS. 1-10, a movable element 55 is positioned on bonetunnel guide rod 25 between first end 30 and second end 40. Movableelement 55 may be moved about on guide rod 25 so that the distance ofmovable element 55 from first end 30 may be selectively adjusted.Movable element 55 may also be secured to guide rod 25 at any of theselongitudinal positions. In one preferred form of the invention, movableelement 55 is movably secured to guide rod 25 using a ratchet systemsuch as that shown in FIGS. 1-10.

The present invention may be practiced with cross-pins of any type, andis independent of the type of cross-pins used in a surgical procedure.Preferably, cross-pins of an absorbable nature are used in a givensurgical procedure. Accordingly, the ACL reconstruction will hereinafterbe discussed in the context of using absorbable cross-pins, and in thecontext of using preferred apparatus for deploying such absorbablecross-pins.

More particularly, in a preferred embodiment using absorbable cross-pins255, 260 (FIG. 34), a trocar sleeve guide member 58 (FIGS. 1-10) isremovably connectable to arm portion 20 of L-shaped member 10. Trocarsleeve guide member 58 is provided with bores 60 extending therethrough.Bores 60 intersect the longitudinal axis 65 of the bone tunnel guide rod25. As such, at least one cross-pin is ultimately positioned in thetibia so as to pass through the tibial tunnel. More preferably, bores 60are configured to intersect the longitudinal axis 65 of bone tunnelguide rod 25 just below the patient's tibial plateau. In this way, theat least one cross-pin will be deployed in the cortical portion of thetibia, adjacent to the tibial plateau, and at the region of greatestbone strength. A set screw 70 may be used to releasably retain trocarsleeve guide member 58 in position on arm portion 20. Alternatively, orin addition, arm portion 20 may be provided with stop means (not shown)for limiting movement of the trocar sleeve guide member 58 along armportion 20. Trocar sleeve guide member 58 is preferably formed in twohalves releasably held together by a set screw 75, whereby trocar sleeveguide member 58 can be detached from first and second trocar sleeves 80,85 passing through bores 60, as will hereinafter be discussed.

First and second trocar sleeves 80, 85 (FIGS. 1-10 and 11-13) areslidably received by bores 60 (FIG. 1) such that sleeves 80, 85 areaxially and rotatably movable in bores 60. Trocar sleeves 80, 85 areeach provided with a collar portion 90 having a diagonally-extendingslot 95 formed therein. Cross-pin guide assembly 5 also preferablyincludes one or more trocars 100 (FIGS. 1-10 and 11-13) for dispositionin sleeves 80, 85. Each trocar 100 is provided with a sharp end 105 forpenetration of bone. A transversely-extending pin 110 is provided near,but spaced from, the opposite end of trocar 100. Pin 110 is fixed inplace and is received by the slot 95 of trocar sleeves 80, 85 such thataxial (in a distal direction) and rotational movement of trocar 100causes similar movement of sleeves 80, 85.

First and second absorbable rods 255, 260 (see FIG. 34), or rods ofother types of known materials, are slidable through sleeves 80, 85, aswill be further described herein below.

In another preferred embodiment, guide member 58 is configured for thedirect placement of cross-pins, without the use of trocar sleeves 80, 85and trocars 100. In this case, the cross-pins are inserted through, andguided by, each of bores 60 in guide member 58.

Referring now to FIG. 14, there is shown a human knee joint 115including a femur 120 and a tibia 125. An appropriate femoral tunnel 130and an appropriate tibial tunnel 135 are provided, as by means andmethods well known in the art. A guidewire 140 extends through thetunnels 130, 135 as shown.

Now looking at FIG. 15, a femoral cross-pinning rack assembly 145, oranother similar system, is provided to position cross-pins 255, 260(FIG. 30) across femoral tunnel 130. Using rack assembly 145, acannulated sleeve 155 is loaded on guidewire 140, passed through tibialtunnel 135 and up into femoral tunnel 130 until the cannulated sleeve'shead portion 160 (FIG. 15) engages in an annular shoulder 165 in femoraltunnel 130. Guidewire 140 extends through a bore 170 (FIG. 15) formed ina base portion 175 of L-shaped member 180. The cannulated sleeve's headportion 160 is preferably sized so as to form a snug fit in femoraltunnel 130. Cannulated sleeve 155 may be positioned in the bone tunnels130, 135 and then connected to L-shaped member 180 or, more preferably,cannulated sleeve 155 may be first connected to L-shaped member 180 andthen positioned in femoral tunnel 130 and tibial tunnel 135. Trocarsleeve guide member 185 (FIG. 15), if not already positioned on an armportion 190, is then fixed to arm portion 190, as by a set screw (notshown).

Now looking at FIG. 16, first trocar sleeve 200 is then inserted in abore 205 of guide member 185 (FIG. 16), and trocar 210 is extendedthrough sleeve 200 until pin 215 of trocar 210 is nestled in slot 220 ofsleeve 200, with the trocar's sharp end 225 extending beyond the distalend of sleeve 200. Alternatively, trocar 210 may be mounted in firsttrocar sleeve 200 before the first trocar sleeve 200 is mounted in bore205. In any case, the combination of trocar sleeve 200 and trocar 210 isthen drilled, as a unit, into femur 120 toward, but stopped short of,the enlarged head portion 160 of cannulated sleeve 155 (FIG. 16).

Trocar 210 may then be withdrawn from first trocar sleeve 200 and placedin a second trocar sleeve 230 (FIG. 17). Alternatively, a second trocar210 may be provided for second trocar sleeve 230. In either case, thecombination of trocar sleeve 230 and trocar 210 is then drilled, as aunit, into femur 120 toward, but again stopped short of, head portion160 of cannulated sleeve 155 (FIG. 17). The rack's L-shaped member 180may then be removed from the surgical site (FIG. 18). This may beaccomplished by first loosening a set screw (not shown) to separatetrocar sleeve guide member 185 into its two halves, whereby trocarsleeves 200, 230 will be freed from guide member 185, and then slidingcannulated sleeve 155 downward along guidewire 140 until the cannulatedsleeve emerges from bone tunnels 130, 135. This procedure will leavetrocar sleeves 200, 230 lodged in femur 120 (FIG. 18).

Referring now to FIG. 19, the bone tunnel guide rod 25 (FIGS. 1-10) isfed over guidewire 140 and up into tibial tunnel 135 until the guiderod's first end 30 is aligned with tibial plateau 235. An arthroscope240 may be used to determine when the guide rod's first end 30 isaligned with tibial plateau 235.

Referring now to FIG. 20, movable element 55 (FIGS. 1-10) is then movedalong guide rod 25 toward the guide rod's first end 30 and tibia 125.When movable element 55 is positioned against tibia 125 (and the guiderod's first end 30 is positioned adjacent tibial plateau 235), movableelement 55 is locked in position such that guide rod 25 cannot travelfurther into tibial tunnel 135. In this configuration, guide assembly 5may be stabilized against tibia 125 by applying a distally-directedforce to guide rod 25, with movable element 55 maintaining the positionof the guide rod relative to tibia 125.

Now looking at FIG. 21, bone tunnel guide rod 25 is shown connected toL-shaped member 10 and positioned in tibial tunnel 135. In oneembodiment, bone tunnel guide rod 25 may be first connected to L-shapedmember 10 and then positioned in tibial tunnel 135. Alternatively, in apreferred embodiment, bone tunnel guide rod 25 is first positioned intibia tunnel 135 and then connected to L-shaped member 10. In eithercase, movable element 55 properly locates bone tunnel guide rod 25relative to tibia 125 so that the guide rod's first end 30 is alignedwith tibial plateau 235. Trocar sleeve guide member 58 (FIGS. 1-10), ifnot already positioned on arm portion 20, is then fixed to arm portion20, such as by set screw 50 (FIGS. 1-10). Guide assembly 5 has ageometry such that when first end 30 of bone tunnel guide rod 25 ispositioned in tibial tunnel 135, and movable element 55 is in engagementwith the front surface of tibia 125, the cross-pins 255, 260 (FIG. 34)will be directed with a desired orientation within the tibial bone and,more preferably, through the strong cortical bone located just below thetibial plateau 235 (FIG. 34).

Now referring to FIG. 22, first trocar sleeve 80 is then inserted inbore 60 of guide member 58, and trocar 100 is extended through sleeve80, with the trocar's sharp end 105 extending beyond the distal end ofsleeve 80. Alternatively, trocar 100 may be mounted in first trocarsleeve 80 before first trocar sleeve 80 is mounted in the guide member'sbore 60. In either case, the combination of trocar sleeve 80 and trocar100 is then drilled, as a unit, into tibia 125 toward, but stopped shortof, the guide rod's passage 35 (FIG. 22).

Trocar 100 may then be withdrawn from first trocar sleeve 80 and placedin second trocar sleeve 85. Alternatively a second trocar 100 may beprovided for second trocar sleeve 85. In either case, the combination oftrocar sleeve 85 and trocar 100 is then drilled (FIG. 23) as a unit intotibia 125 toward, but stopped short of, the guide rod (FIG. 24).

The guide assembly's L-shaped member 10 may then be removed from thesurgical site. This may be accomplished by first loosening set screw 75(FIGS. 1-10) so as to separate trocar sleeve guide member 58 into itstwo halves, whereby trocar sleeves 80, 85 will be freed from guidemember 58, and then sliding bone tunnel guide rod 25 downward alongguidewire 140 until the guide rod 25 emerges from tibial bone tunnel135. This procedure will leave trocar sleeves 80, 85 lodged in tibia 125(FIG. 25).

Significantly, due to the geometry of guide assembly 5, trocar sleeves80, 85 (and hence cross-pins 255, 260) will be directed into the strongcortical bone located just beneath tibial plateau 235.

Guidewire 140 is then used to pull a suture 245, which is attached to agraft ligament 250 (including, but not limited to, soft tissue graftsand bone block grafts) up through tibial tunnel 135 and into femoraltunnel 130, until graft ligament 250 engages the annular shoulder 165 infemoral tunnel 130 (FIG. 26). Guidewire 140 may be provided with aneyelet (not shown) adjacent to its proximal end so as to facilitate thisprocedure. Graft ligament 250 can then be held in this position bymaintaining tension on the portion of suture 245 emerging from the topof femur 120.

Trocar 210 may then be removed from second trocar sleeve 230, placed infirst trocar sleeve 200, and then sleeve 200 and trocar 210 drilledthrough the distal end of graft ligament 250, as shown in FIG. 27.Trocar 210 may then be removed from sleeve 200, placed in second sleeve230, and second sleeve 230 and trocar 210 drilled through the distal endof graft ligament 250, as also shown in FIG. 27. The trocar 210 (ortrocars 210 if more than one trocar is used) may then be withdrawn fromsleeves 200, 230 (FIG. 28). A first absorbable rod 255 (FIG. 29) is thendeployed, by sliding rod 255 through trocar sleeve 200, into a positionextending through ligament 250. Sleeve 200 may then be withdrawn fromligament 250 and femur 120, leaving first absorbable rod 255 in place infemur 120 and extending through ligament 250. Similarly, secondabsorbable rod 260 may be slid into place through sleeve 230. Sleeve 230is then removed, leaving second absorbable rod 260, along with firstabsorbable rod 255, extending through ligament 250 so as to lockligament 250 in place in femoral tunnel 130, as shown in FIG. 29.

Looking next at FIG. 30, graft ligament 250 is then held in position bymaintaining tension on the proximal portion of ligament 250 emergingfrom the bottom of tibia 125

Next, graft ligament 250 is attached to tibia 125. More particularly,first trocar sleeve 80 and a trocar 100 are drilled through ligament250, as shown in FIG. 31. Trocar 100 may then be removed from firstsleeve 80, placed in second sleeve 85, and second sleeve 85 and trocar100 drilled through ligament 250, as shown in FIG. 32. Alternatively, asecond trocar 100 may be provided for use with second sleeve 85. Ineither case, after trocar sleeves 80 and 85 have been set, the trocar100 (or trocars 100, if more than one trocar is used) may then bewithdrawn from sleeves 80, 85 (FIG. 33). A first absorbable rod 255 isthen inserted, by sliding rod 255 through trocar sleeve 80, into aposition extending through ligament 250. Sleeve 80 may then be withdrawnfrom ligament 250 and tibia 125, leaving first absorbable rod 255 inplace in tibia 125 and extending through ligament 250. Similarly, asecond absorbable rod 260 is then slid into place through sleeve 85.Sleeve 85 is then removed, leaving second absorbable rod 260, along withfirst absorbable rod 255, extending through ligament 250 so as to lockligament 250 into place in tibial tunnel 135, as shown in FIG. 34.

Now referring to FIGS. 35-38, there is shown a bone tunnel referenceguide 265 for placement of at least one cross-pin (not shown in FIGS.35-38) in a bone tunnel such as the tibial tunnel of a knee joint. Bonetunnel reference guide 265 may be used in procedures to fix graftligaments (including both soft tissue grafts and bone block grafts) inbone tunnels. Bone tunnel reference guide 265 comprises an L-shapedmember 270 having a base portion 275 and an arm portion 280. The armportion 280 extends transversely to, and preferably is normal to, baseportion 275.

Bone tunnel reference guide 265 further comprises a bone tunnel guiderod 285 having a first end 290 and a second end 295. Bone tunnel guiderod 285 includes a gradiated index 300 between first end 290 and secondend 295. Bone tunnel guide rod 285 includes a diametrically-extending,longitudinally-elongated passageway 305 intermediate its length and, atsecond end 295, is connected to base portion 275 of L-shaped member 270.In a preferred embodiment, bone tunnel guide rod 285 is cannulated at306 (FIG. 35) for placement on a guidewire (not shown in FIG. 35). Bonetunnel guide rod 285 may be retained in a bore 315 formed in baseportion 275 by a pin 320.

Still looking at FIGS. 35-38, a scale 325 is provided on arm portion 280of L-shaped member 270. Scale 325 is coordinated with gradiated index300 on bone tunnel guide rod 285 as will hereinafter be discussed.

The present invention may be practiced with cross-pins of any type, andis independent of the type of cross-pins used in a surgical procedure.Preferably, cross-pins of an absorbable nature are used in a givensurgical procedure. Accordingly, the ACL reconstruction will hereinafterbe discussed in the context of using absorbable pins, and in the contextof using preferred apparatus for deploying such absorbable pins.

More particularly, in a preferred embodiment using absorbablecross-pins, a trocar sleeve guide member 330 is removably connectableto, and selectably adjustable along, scale 325 of arm portion 280 ofL-shaped member 270. Trocar sleeve guide member 330 is provided withbores 335 extending therethrough. Bores 335 extend through alongitudinal axis 340 of bone tunnel guide rod 285. As such, at leastone cross-pin is ultimately positioned in the tibia so as to passthrough the tibial tunnel. More preferably, bores 335 are configured tointersect the longitudinal axis 340 of bone tunnel guide 285 just belowthe patient's tibial plateau. In this way, the at least one cross-pinwill be deployed in the cortical portion of the tibia, adjacent to andjust below the tibial plateau, and at the region of greatest bonestrength. A set screw 345 may be used to releasably retain trocar sleeveguide member 330 in position along scale 325 of arm portion 280. Trocarsleeve guide member 330 is preferably formed in two halves releasablyheld together by a set screw 350, whereby trocar sleeve guide member 330can be detached from first and second trocar sleeves 355, 360 passingthrough bores 335, as will hereinafter be discussed.

In another preferred embodiment, trocar sleeve guide member 330 isconfigured for direct placement of cross-pins, without the use of trocarsleeves 355, 360. In this case, cross-pins are inserted through, andguided by each of bores 335 in guide member 330.

Bone tunnel reference guide 265 is preferably used as follows. First,femoral tunnel 130 and tibial tunnel 135 (FIG. 14) are formed. Then thereference guide's guide rod 285 (FIGS. 35-38) is passed up tibial tunnel135 and femoral tunnel 130 until the distal end 290 of guide rod 285 isin engagement with the distal end 165 of femoral tunnel 130 (FIG. 14).As this occurs, the reference guide's L-shaped member 270 will supporttrocar sleeve guide member 30 outboard of the patient's femur.Stabilization of the bone tunnel reference guide 265 is provided byapplying a distally-directed force to guide rod 285, which is inengagement with the distal end 165 of femoral tunnel 130. Thisstabilization allows accurate placement of the cross-pins. Then anarthroscope is used to read the gradiated index 300 at the point atwhich guide rod 285 crosses the tibial plateau. Trocar sleeve guidemember 330 is then set at a corresponding location along its own scale325. In this respect it will be appreciated that gradiated index 300 iscoordinated with scale 325 so that the axes of bores 335 (FIG. 35), andhence the cross-pins, will pass through the tibia at a desired position,such as through the tibia's cortical bone just below the tibial plateau.

Next, drill sleeves 355, 360 are used to set trocars 365, 370 into thetibia. Trocar sleeve guide member 330 is then separated into its twohalves so as to free drill sleeves 355, 360 from reference guide 265,and the reference guide 265 is removed from the surgical site, e.g., bywithdrawing it proximally off the guidewire. Then the graft ligament ispulled up into femoral tunnel 130 and tibial tunnel 135, the distal endof the graft ligament is made fast in femoral tunnel 130, and then drillsleeves 355, 360 are used to set absorbable cross-pins through theproximal end of the graft ligament, whereby to cross-pin the ligament tothe tibia.

Now looking at FIG. 39, there is shown a kit 300 of bone tunnel guiderods 305 for use with a cross-pin guide assembly such as the cross-pinguide assembly 308 shown in FIG. 40. In one preferred form of theinvention, cross-pin guide assembly 308 is similar to the cross-pinguide assembly 5 shown in FIGS. 1-10, except that bone tunnel guide rod25 of cross-pin guide assembly 5 is replaced with one of the bone tunnelguide rods 305 shown in FIG. 39.

Each of the bone tunnel guide rods 305 includes a proximal end 310 and adistal end 315. As insertion limiting means 320, for limiting insertioninto a bone tunnel, is located between proximal end 310 and distal end315. Preferably insertion limiting means 320 comprises an annularshoulder formed intermediate the distal end 321 and the proximal end 322of a given bone tunnel guide rod 305.

Insertion limiting means 320 are located at a given distance 325 fromthe distal end 321 of bone tunnel guide rods 305. Each kit 300 includesat least two bone tunnel guide rods, with the given distance 325 of eachof the tunnel guide rods being different from one another. As such,selection is made from kit 300 by inserting at least one of the bonetunnel guide rods 305 into a bone tunnel and selecting the one of thebone tunnel guide rods 305 that has its distal end 321 aligned with thepatient's tibial plateau when insertion limiting means 320 are inengagement with the front side of the patient's tibia. As a result ofthis construction, when that selected bone tunnel guide rod 305 isloaded in cross-pin guide assembly 308, bores 60 (FIG. 40), and hencethe cross-pins, will be aimed at the thick cortical bone directlybeneath the tibial plateau, whereby to enable secure and reliable tibialcross-pinning.

In many circumstances the bone tunnel's “angle of attack” may vary, andthis can have an effect on how the drill sleeves need to be positionedrelative to the bone. More particularly, in FIG. 41 there are shown twodifferent bone tunnels BT formed in a tibia T. In general, it isdesirable to place the two drill sleeves S parallel to the top surfaceTS of tibia T, and to terminate the distal ends of the drill sleevesapproximately 2 mm or so from the distal ends of the bone tunnel. Thus,as seen in FIG. 41, the relative positions of the drill sleeves S willvary according to (1) the angle of attack of bone tunnel BT, and (2)which drill sleeve is closer to the top surface TS of tibia T.

In an aspect of the present invention, apparatus can be provided tofacilitate this variable positioning of the drill sleeve relative to thebone.

More particularly, and looking next at FIGS. 42-44, there is shown anapparatus 400 for positioning at least one cross-pin (not shown in FIGS.41-43, but represented by drilling means 405) in a bone through a bonetunnel. Apparatus 400 includes a bone tunnel guide rod 410 having aproximal end 415 and a distal end 420. A frame member 425 has a baseportion 430 and an arm portion 431. Base portion 430 is attachable toproximal end 415 of bone tunnel guide rod 410. A pair of slots 440 areformed in arm portion 431, with the slots 440 being arced outwardlyrelative to bone tunnel guide rod 410. More particularly, the slots 440extend outwardly from bone tunnel guide rod 410, with slots 440 beingfurther from distal end 420 than proximal end 415. Furthermore, the twoslots 440 are preferably not concentric with one another, with the twoslots being spaced closer together the further out they extend along armportion 431.

A drill guide member 445 slidably carries a pair of carriages 441 on itsbody. Each of the carriages 441 has a pin 442 which rides in a slot 440,whereby carriages 441 can be cammed relative to drill guide member 445as the drill guide is moved relative to arm portion 431. Carriages 441slidably receive drilling means 405 therein. Drill guide member 445 hasa probe 450 which is attachable to distal end 420 of bone tunnel guiderod 410. Probe 450 acts to guide the positioning of the at least onedrilling means 405. Drilling means 405 drill at least one cross-pin hole(not shown) in the bone and across the bone tunnel, with the drillingmeans 405 being supported in position by carriages 441, which areslidably supported by drill guide member 445. Drill guide member 445 isin slidable connection with frame member 425, which is in attachmentwith bone tunnel guide rod 410.

In use, bone tunnel guide rod 410 is inserted into the bone tunnel andprobe 450 is then attached to distal end 420 of bone tunnel guide rod410 to position the drill guide member 445 so as to place at least onecross-pin (not shown) in a bone through a bone tunnel. Inasmuch ascarriages 441 are movably attached to drill guide member 445, and drillguide member 445 is movably attached to frame member 425, and inasmuchas carriages 441 are cammed by the two slots 440, and the two slots 440are oriented outwardly, carriages 441 can move towards and away frombone tunnel guide rod 410 as the drill guide member 445 moves down andup frame member 425, respectively. Thus, the construction of apparatus400 allows carriages 441 and drill guide member 445 to adjust to achanging angle and distance relative to a desired cross-pin site. Thiscan be extremely beneficial where the cross-pins are to be set for avariety of different bone tunnel angles using trocar sleeves of a fixedlength.

Apparatus 400 may be used as follows to fix a ligament in a bone tunnelin the bone. First, a bone tunnel is formed in the bone, where the bonetunnel comprises a first open end and the second open end, with aportion between the first open end and the second open end having adiameter sized to receive the ligament. For example, this may be atibial tunnel formed in a patient's tibia. Then bone tunnel guide rod410 is inserted into the bone tunnel so that the guide rod's distal endis adjacent to the patient's tibial plateau. Then a drill guide member445 is slid along the at least one slot 440 until the inner tip of probe450 engages distal end 420 of guide rod 410. The cammed nature of slots440 causes carriages 441 to adjust to a changing angle and distancerelative to the desired cross-pin site. Then at least one cross-pin holeis drilled transversely through the bone and across the bone tunnel,using drilling means 405. Apparatus 400 is then removed, permitting across-pin to be inserted in the cross-pin hole so as to cross-pin agraft ligament to the bone.

It is to be understood that the present invention is by no means limitedto the specific applications thereof as herein disclosed and/or shown inthe drawings. For example, for illustrative purposes, the inventivemethod and apparatus are described herein and illustrated with referenceto the human knee joint. It is anticipated that the method and apparatusdescribed herein will be particularly beneficial with respect to suchoperations. However, it will also be appreciated by those skilled in theart that the method and apparatus described herein will find utilitywith respect to mammals generally, and with respect to other bones as,for example, in shoulder joints or the like.

Furthermore, trocars 100 and 210 are disclosed herein as being in theform of a hard rod with a sharp tip for penetrating bone. Thus, forexample, trocars 100 and 210 might comprise guidewires of K-wires with apyramidal front point. Alternatively, however, the invention might alsobe practiced with trocars 100 and 210 comprising a twist drill, a spadedrill and/or some other sort of drill.

Also it is contemplated that trocars 100 and/or 210 might be used withtheir associated guide member 58, rack assembly 145, reference guide265, guide assembly 308 and/or apparatus 400 to set absorbable rods 255,260, but without their associated sleeves 80, 85, and 200, 230,respectively. In this case, at least one trocar would always remainpositioned in graft ligament 250 until at least one absorbable rod 255,260 was positioned in the bone block.

If desired, it is also possible to practice the present invention usingjust one sleeve 80 and one trocar 100, or just one sleeve 85 and onetrocar 100, or just one sleeve 200 and one trocar 210, or without usingsleeves and/or trocars at all.

Numerous further variations, alterations, modifications and otherderivations of the present invention will occur and/or become obvious tothose skilled in the art in view of the foregoing detailed descriptionof the preferred embodiments of the present invention. Accordingly, itis to be understood that the foregoing specification and the appendeddrawings are intended to be illustrative only, and not as limiting ofthe invention.

1. A method for fixing a ligament in a bone tunnel, said methodcomprising the steps of: forming a bone tunnel in a bone, said bonetunnel comprising a first open end and a second open end, with a portionbetween said first open end and said second open end having a diametersized to receive the ligament; inserting a bone tunnel guide rod intosaid bone tunnel, said bone tunnel guide rod having a proximal end and adistal end; positioning a drill guide member slidably connected with aframe member, said frame member being attached to said proximal end ofsaid drill guide member, said frame member having a probe connected tosaid drill guide member, with said drill guide member being positionedso that said probe is connected to said distal end of said bone tunnelguide rod, with such positioning causing said drill guide member toadjust to a changing angle and distance relative to a desired cross-pinsite; drilling at least one cross-pin hole transversely through saidbone and across said bone tunnel, using drilling means for drilling saidcross-pin hole, said drilling means being supported in position by saiddrill guide member, with said drill guide member being in slidableattachment with said frame member, said frame member being in attachmentwith said proximal end of said bone tunnel guide rod, said bone tunnelguide rod being inserted into said bone tunnel, and with said probebeing in engagement with said distal end of said bone tunnel guide rod;and inserting at least one cross-pin through said at least one cross-pinhole; wherein said probe is in engagement with said distal end of saidbone tunnel guide rod prior to the step of drilling said at least onecross-pin hole transversely through said bone and across said bonetunnel.
 2. The method of claim 1, wherein said bone tunnel guide rod isfixedly connected to said frame member.
 3. The method of claim 1,wherein said bone tunnel guide rod is removably connected to said framemember.
 4. The method of claim 3, wherein said bone tunnel guide rod isattached to said frame member prior to the step of inserting said bonetunnel guide rod into said bone tunnel.
 5. The method of claim 3,wherein said bone tunnel guide rod is attached to said frame memberafter the step of inserting said bone tunnel guide rod into said bonetunnel.
 6. The method of claim 1, further comprising the step ofremoving said bone tunnel guide rod prior to the step of inserting atleast one cross-pin through said at least one cross-pin hole.
 7. Amethod for fixing a ligament in a bone tunnel, said method comprisingthe steps of: forming a bone tunnel in a tibia, said bone tunnelcomprising a first open end and a second open end, with a portionbetween said first open end and said second open end having a diametersized to receive the ligament; inserting a bone tunnel guide rod intosaid bone tunnel, said bone tunnel guide rod having a proximal end and adistal end; positioning a drill guide member slidably connected with aframe member, said frame member being attached to said proximal end ofsaid drill guide member, said frame member having a probe connected tosaid drill guide member, with said drill guide member being positionedso that said probe is connected to said distal end of said bone tunnelguide rod, with such positioning causing said drill guide member toadjust to a changing angle and distance relative to a desired cross-pinsite; drilling at least one cross-pin hole transversely through saidtibia and across said bone tunnel, using drilling means for drillingsaid cross-pin hole, said drilling means being supported in position bysaid drill guide member, with said drill guide member being in slidableattachment with said frame member, said frame member being in attachmentwith said proximal end of said bone tunnel guide rod, said bone tunnelguide rod being inserted into said bone tunnel, and with said probebeing in engagement with said distal end of said bone tunnel guide rod;and inserting at least one cross-pin through said at least one cross-pinhole.
 8. The method of claim 7, wherein inserting said bone tunnel guiderod into said bone tunnel comprises positioning said distal end of saidbone tunnel guide rod adjacent a tibial plateau of said tibia, saiddistal end of said bone tunnel guide rod being adjacent said tibialplateau when said at least one cross-pin hole is drilled transverselythrough said tibia and across said bone tunnel.
 9. The method of claim7, wherein said probe is in engagement with said distal end of said bonetunnel guide rod prior to the step of drilling said at least onecross-pin hole transversely through said tibia and across said bonetunnel.
 10. The method of claim 7, wherein said probe is connected tosaid drill guide member prior to the step of positioning said drillguide member, and positioning said drill guide member causes said probeto be connected to said distal end of said bone tunnel guide rod. 11.The method of claim 1, wherein positioning said drill guide memberslidably connected with a frame member comprises sliding said drillguide member relative to said frame member until a distal end of saidprobe engages said distal end of said bone tunnel guide rod.
 12. Themethod of claim 1, wherein said probe is connected to said drill guidemember prior to the step of positioning said drill guide member, andpositioning said drill guide member causes said probe to be connected tosaid distal end of said bone tunnel guide rod.